临床试验的监查刘玉成.ppt

临床试验的监查
惠氏制药有限公司临床研究开发部
刘玉成 医学督导
2020/11/3
1
2020/11/3
2
临床试验监查的目的
保证临床试验中受试者的权益受到保障
保证试验记录与报告的数据准确、完整无误
保证试验遵循已批准的方案和有关法规进行
ICH GCP
2020/11/3
3
监查员（Monitor）的角色和作用
监查员是申办者与研究者之间的主要联系人
ICH GCP
2020/11/3
4
合格的Monitor应具备的条件
应有适当的医学、药学或相关专业学历
经过必要的培训
应熟悉药品管理有关法规
应熟悉有关试验药物的临床前和临床方面的信息
应熟悉临床试验方案及其相关的文件
2020/11/3
5
临床试验监查的种类
研究中心启动的拜访 (Site Initiation Visit)
研究进行中的拜访 (Site Monitoring Visit)
受试者访视完成后的拜访 (Site Closeout Visit)
2020/11/3
6
Monitoring Visit Intervals
The above monitoring visit intervals are given as an example. Actual monitoring visit internals shall be defined in the monitoring plan.
SDV: source data verification will be performed after site personnel has transcribed data into CRF
Monitoring Period
Recommended Target
Site Initiation Visit
Within 1-2 weeks prior to first patient visit.
1st Monitoring Visit
As soon as practical, but no later than 2 weeks after the first patient visit.
Between First and Last Subject Visit
Every 2 weeks, including one dosing day and one pharmacokinetic sampling day.
Last Monitoring Visit
Within 2 weeks after the site’s last subject visit
Closeout Visit
After resolution of all data queries sent to the site
2020/11/3
7
Pre-study visit
Pre-study
Post-study
Close out visit
Monitoring Plan
2. Monitoring Reports
1. Query Log
Study Monitoring Process Outline
Live Phase Study Period
Screening
Study Entry
First dosing & PK
Multiple PK
Check ICD, I/E
Check dosing & PK
Perform source data verification
Follow Up visit
2020/11/3
8
临床试验监查的步骤安排
监查拜访前的准备
监查拜访中的职责
监查拜访后的跟踪
2020/11/3
9
临床试验监查的步骤安排
监查拜访前的准备
2020/11/3
10